There are several
ways to speed up a clinical trial management system (CTMS) implementation,
including choosing an accelerator and having it hosted in the cloud. Both of
these concepts have existed for a few years and have gained a lot of traction. Organizations
that opt for accelerators in the cloud have learned that it gives them a big
leg up on the competition.

Now, there is
another way to speed things up. It is a project management approach called “Rolling
Releases.” MannKind Corporation (MannKind) completed an implementation
in July of Siebel Clinical, Oracle’s CTMS that involved an accelerator, the cloud, and
rolling releases. Read on to learn more about their thought process and
experience with employing all three accelerator methods together.

Given the anticipated success of MannKind’s innovative
insulin therapy called AFREZZA and plans for research into additional
applications of their therapeutic approach, the company recognized the need to
replace their existing CTMS with a more comprehensive, user-friendly CTMS,
particularly one with advanced site payment functionality and the ability to
integrate with their clinical data management and electronic data capture (EDC)
systems, Oracle Clinical / Remote Data Capture (OC/RDC). Based on their planned
clinical trial schedule, they knew they needed a solution in place quickly,
despite knowing that implementations involving integrations generally take a
long time. The organization also knew they did not have the necessary
information technology resources to implement and maintain a system in-house,
so they needed a CTMS in the cloud.

Planning With a Tight Timeline

MannKind selected BioPharm Systems’ pre-configured version
of Oracle’s Siebel Clinical solution, ASCEND, part of the Oracle Accelerate
program. Although the CTMS accelerator met most of their requirements
out-of-the-box, the remaining requirements revolved around a collection of
intelligent site payment enhancements and the integration with OC/RDC. Due to
MannKind’s tight timeline, BioPharm proposed an innovative approach to the
project that involved “rolling releases,” meaning that the work would be
divided into separate, logical work streams that could be executed largely in
parallel, thus significantly shortening the overall project timeline. In
addition, BioPharm proposed that one of those work streams be the
implementation and release of the base version of ASCEND, so that MannKind
could begin benefiting from their new system while the other work streams were
still in progress. MannKind’s custom and integrated system would also be hosted
and managed by BioPharm in a private cloud.

A Three Pronged Parallel Approach

The project was divided into three work streams:

Implementation of the base version of ASCEND

Application changes

EDC integration

The project began with the parallel installation of the
development (Dev) and production (Prod) environments of the base version of
ASCEND. While the computer systems validation activities were being conducted
for Prod, the application changes and integration coding began in Dev. Once
Prod was validated, BioPharm cloned the environment to create the validation
(Val) environment to be used for testing the additional work streams. When Prod
and Val were fully validated, BioPharm trained MannKind and Prod was released
for use. MannKind began using the system right away, entering clinical
administration data, as well as building their investigator database.

Ahead of Schedule

Just six weeks later, the application changes were validated
and released to Prod for use. This work stream was released nearly three weeks
ahead of schedule, allowing MannKind to expand their data entry to include
study, country, and site-specific information even sooner than planned.

Just four weeks after the application changes went live, the
EDC integration work stream was validated and released to Prod for use. This
work stream was also completed nearly three weeks early, providing MannKind
with all three work streams in just three months; all validated, all integrated
with Active Directory, and all hosted and managed by BioPharm in a private
cloud.

Time = Money

BioPharm’s approach to the CTMS implementation and
integration at MannKind resulted in:

An estimated time savings of 3-4 months per work
stream

Quicker return on investment (ROI)

Increased user adoption, due to receiving the
system sooner and learning to use it in smaller chunks

Long-term cost savings due to private cloud
hosting services

In this fast-paced industry in which so much depends on
being first-to-market, we expect to see more time-saving innovations around
CTMS and other system implementations. Accelerators, hosting and, now, rolling
releases. We are excited to see what comes next.